Regulations for Good Clinical Practice Article 47
The sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator and the institution against claims arising from the trial, except for claims that arise from malpractice and/or negligence.
中文原文 藥品優良臨床試驗作業準則第47條
試驗委託者應負責試驗主持人或試驗機構因試驗所生之賠償責任或投保責任保險。
但因試驗主持人或試驗機構之醫療疏失所致者，不在此限。
但因試驗主持人或試驗機構之醫療疏失所致者，不在此限。